Tebentafusp
- Generic Name
- Tebentafusp
- Brand Names
- Kimmtrak
- Drug Type
- Biotech
- CAS Number
- 1874157-95-5
- Unique Ingredient Identifier
- N658GY6L3E
- Background
Tebentafusp is a gp100 peptide-HLA-directed CD3 T cell engager. It is a bispecific, fusion protein and first-in-class drug of immune-mobilizing monoclonal T cell receptors against cancer (ImmTACs), a recently developed cancer immunotherapy with a novel mechanism of action. ImmTACs bind to target cancer cells that express a specific antigen of interest and recruit cytotoxic T cells to lyse the cells, such as melanocytes.
Uveal melanoma is a rare ocular tumour with often poor prognosis and limited treatment options. Even after surgical ablation or removal of the ocular tumour, almost 50% of patients with uveal melanoma develop metastatic disease. On January 26, 2022, tebentafusp was first approved by the FDA for the treatment of HLA-A*02:01-positive adults with unresectable or metastatic uveal melanoma. This approval marks the first bispecific T cell engager to be approved by the FDA to treat a solid tumour and being the first and only therapy for the treatment of unresectable or metastatic uveal melanoma to be approved by the FDA. Tebentafusp was subsequently approved for the same indication in the EU in April 2022.
- Indication
Tebentafusp is indicated for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
- Associated Conditions
- Metastatic Uveal Melanoma, Unresectable Uveal Melanoma
A Phase II Trial of Tebentafusp in HLA-A*02:01 Positive Patients With Advanced Clear Cell Sarcoma
- Conditions
- HLA-A*0201 Positive Cells PresentClear Cell Sarcoma (CCS)
- Interventions
- Drug: Physician's Choice
- First Posted Date
- 2025-04-24
- Last Posted Date
- 2025-04-24
- Target Recruit Count
- 47
- Registration Number
- NCT06942442
Study of Tebentafusp and Radioembolization in the Treatment of Metastatic Uveal Melanoma
- Conditions
- Metastatic Uveal MelanomaMetastatic Uveal Melanoma in the Liver
- Interventions
- Radiation: TheraSphere™ Yttrium-90 Trans-Arterial Radioembolization
- First Posted Date
- 2024-10-04
- Last Posted Date
- 2025-02-19
- Lead Sponsor
- University of Miami
- Target Recruit Count
- 30
- Registration Number
- NCT06627244
- Locations
- 🇺🇸
University of Miami, Miami, Florida, United States
Adjuvant Tebentafusp in High Risk Ocular Melanoma
- First Posted Date
- 2024-02-07
- Last Posted Date
- 2025-05-01
- Target Recruit Count
- 290
- Registration Number
- NCT06246149
- Locations
- 🇧🇪
Cliniques Universitaires Saint-Luc, Brussels, Belgium
🇫🇷Institut Curie - Hôpital de Paris, Paris, France
🇩🇪Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin, Berlin, Germany
Tebentafusp in HLA-A*0201 Positive Previously Untreated Metastatic Uveal Melanoma
- First Posted Date
- 2023-10-06
- Last Posted Date
- 2025-03-17
- Lead Sponsor
- Diwakar Davar
- Target Recruit Count
- 44
- Registration Number
- NCT06070012
- Locations
- 🇺🇸
UPMC Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Tebentafusp Regimen Versus Investigator's Choice in Previously Treated Advanced Melanoma (TEBE-AM)
- Conditions
- Advanced Melanoma
- Interventions
- First Posted Date
- 2022-09-22
- Last Posted Date
- 2025-04-30
- Lead Sponsor
- Immunocore Ltd
- Target Recruit Count
- 540
- Registration Number
- NCT05549297
- Locations
- 🇺🇸
University of Utah Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇩🇪Charité - Campus Charité Mitte, Berlin, Germany
🇩🇪Universitaetsklinikum Erlangen, Erlangen, Germany
Tebentafusp in Molecular Relapsed Disease (MRD) Melanoma
- First Posted Date
- 2022-04-07
- Last Posted Date
- 2025-02-10
- Lead Sponsor
- University of Oxford
- Target Recruit Count
- 850
- Registration Number
- NCT05315258
- Locations
- 🇬🇧
Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, United Kingdom
🇬🇧The Clatterbridge Cancer Centre, Liverpool, United Kingdom
🇬🇧The Christie Hospital, Manchester, United Kingdom
A Cohort IND Expanded Access Program for Supporting Patient Access to Tebentafusp
- Conditions
- Uveal Melanoma
- First Posted Date
- 2021-07-14
- Last Posted Date
- 2022-01-21
- Lead Sponsor
- Immunocore Ltd
- Registration Number
- NCT04960891
Safety and Efficacy of IMC-F106C as a Single Agent and in Combination With Checkpoint Inhibitors
- Conditions
- Select Advanced Solid Tumors
- Interventions
- Drug: Brenetafusp and chemotherapyDrug: Brenetafusp and monoclonal antibodies and chemotherapyDrug: Brenetafusp and bevacizumabDrug: Brenetafusp and kinase inhibitors
- First Posted Date
- 2020-02-10
- Last Posted Date
- 2025-04-30
- Lead Sponsor
- Immunocore Ltd
- Target Recruit Count
- 727
- Registration Number
- NCT04262466
- Locations
- 🇵🇱
Centrum Medyczne Pratia Poznan - Skorzewo, Skórzewo, Poland
🇵🇱Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy, Warszawa, Poland
🇪🇸Universidad de Navarra - Clinica Universidad de Navarra (CUN) - Pamplona, Pamplona, Navarra, Spain
Safety and Efficacy of IMCgp100 Versus Investigator Choice in Advanced Uveal Melanoma
- Conditions
- Uveal Melanoma
- Interventions
- First Posted Date
- 2017-03-03
- Last Posted Date
- 2025-04-22
- Lead Sponsor
- Immunocore Ltd
- Target Recruit Count
- 378
- Registration Number
- NCT03070392
- Locations
- 🇨🇦
Cross Cancer Institute, Edmonton, Alberta, Canada
🇨🇦Princess Margaret Cancer Centre, Toronto, Canada
🇫🇷Centre Atoine Lacassagne, Nice, France
IMCgp100-401 Rollover Study
- First Posted Date
- 2016-09-07
- Last Posted Date
- 2020-07-27
- Lead Sponsor
- Immunocore Ltd
- Target Recruit Count
- 3
- Registration Number
- NCT02889861
- Locations
- 🇬🇧
Dept of Medical Oncology, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom
🇺🇸Memorial Slone Kettering Cancer Center, New York, New York, United States
🇬🇧Dept of Oncology & Haematology, Churchill Hospital, Oxford, Oxfordshire, United Kingdom
Drug Development Updates
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